-- RELAX-AHF study met one of its two primary endpoints in
reducing dyspnea or shortness of breath, and was therefore positive
under pre-specified criteria
-- Newly presented data show that at six months, RLX030 reduced
all-cause and cardiovascular mortality by 37% in patients with
acute heart failure (AHF)
-- RLX030 is the first in a new class of medicines and the only
agent to show a reduction in mortality in AHF
-- Within one year after hospitalization for AHF, approximately
20-30% of patients die from various causes

EAST HANOVER, N.J., Nov. 6, 2012 /PRNewswire/ -- The Phase III
RELAX-AHF study has shown that investigational RLX030 (serelaxin)
improved symptoms and reduced deaths by one-third at the end of six
months in patients with acute heart failure (AHF). Most of these
deaths were due to cardiovascular causes. RLX030 is the first in a
new class of medicines and is believed to act through multiple
mechanisms on the heart, kidneys and blood vessels.

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RELAX-AHF demonstrated that RLX030 significantly reduced dyspnea
(i.e. shortness of breath), the most common symptom of AHF and the
primary endpoint of the study. As one of two co-primary endpoints
was met, the study achieved its primary objective based on
pre-specified protocol criteria.

Results of the study were presented today at the American Heart
Association (AHA) Scientific Sessions in Los Angeles and published
simultaneously in The Lancet.

"This study with serelaxin is important because it may offer the
prospect of a much-needed new medicine for acute heart failure,
where the death rate remains high and there have been few new
therapies for several decades," said Professor John R. Teerlink, MD
of the Section of Cardiology, San Francisco Veterans Affairs
Medical Center, University of California, San Francisco, the
co-lead investigator of the RELAX-AHF study.

Professor Marco Metra, Director of the Institute of Cardiology
at the University and Civil Hospital of Brescia, Italy, the other
co-lead investigator of the study, said: "The reduction in
mortality seen with serelaxin is supported by the decreases in
episodes of worsening of heart failure, as well as by the biomarker
data collected during the study, suggesting that the clinical
effects of serelaxin may be linked to a beneficial effect on organs
such as the heart and kidneys."

Novartis has begun discussing the results of this single Phase
III study with health authorities worldwide.

"The survival results with RLX030 are encouraging for patients,
their families and society at large," said Tim Wright, Global Head
of Development, Novartis Pharmaceuticals. "Novartis is committed to
significantly improving treatment outcomes for patients with heart
failure, and these results support our research into this
therapeutic area which may lead to better management of the
disease."

Study details
RELAX-AHF was an international randomized, double-blind study
involving 1,161 patients and was designed to compare the efficacy
and safety profile of RLX030 to placebo in addition to standard
therapy for the treatment of AHF. RLX030 was given upon
hospitalization in the form of an intravenous infusion (30 mcg per
kg per day) for 48 hours in addition to conventional therapy for
AHF, i.e. loop diuretics and other medicines.

The study had two primary endpoints using different scales to
measure reduction in dyspnea. The visual analog scale (VAS) showed
a significant benefit up to day five (p=0.0075), whereas the Likert
scale (a baseline-related short-term assessment of dyspnea relief)
did not reach significance at 6, 12 and 24 hours (p=0.702). As one
of the primary endpoints was met the study was positive according
to protocol criteria.

The study did not meet its secondary efficacy endpoints, namely
days alive and out of hospital up to day 60 (p=0.37), and
cardiovascular death or re-hospitalization due to heart or kidney
failure up to day 60 (p=0.89).

Results showed that 7.3% of patients died from all causes in the
RLX030 group compared to 11.3% in the placebo group (p=0.02) at 180
days of follow-up. All-cause mortality up to day 180 was a safety
endpoint of the study. The number of deaths due to cardiovascular
causes to day 180 (an additional pre-specified efficacy endpoint)
was also significantly lower with RLX030 than placebo (6.1% vs.
9.6%, p=0.028). RLX030 was therefore associated with a 37%
reduction in all-cause and cardiovascular mortality at the end of
six months.

In addition to its effects on mortality and symptoms, RLX030 met
several other efficacy endpoints including significantly reducing
the worsening signs and symptoms of heart failure up to day 14
(p=0.024), thereby decreasing the need for intensified heart
failure treatment. RLX030 also reduced the mean length of stay in
hospital by 0.9 days (p=0.039) and in the intensive/cardiac care
unit by 0.4 days (p=0.029).

RLX030 was well tolerated and adverse events (AEs), including
low blood pressure (hypotension), were generally comparable between
RLX030 and placebo. There was a lower incidence of adverse events
related to renal impairment with RLX030 than placebo (4.6% vs.
8.6%). The most common AEs in both treatment groups were cardiac
disorders, metabolism and nutrition disorders, and gastrointestinal
disorders. No clinically significant differences in the incidence
of serious adverse events were seen between treatment groups.

Heart failure is a disease in which the heart is unable to
supply enough blood to meet the body's needs. The disease leads to
a spiral of physical decline often leading to acute episodes in
which patients' symptoms suddenly become worse and urgent hospital
treatment is needed. These episodes are called acute heart failure
(AHF) and are also referred to as acute decompensated heart
failure. Acute heart failure (AHF) places an enormous burden on
healthcare systems. It is the most frequent cause of
hospitalization in patients over 65 years of age in the United
States. Death rates remain high despite currently available
treatments. In 2009, there were more than 650,000 AHF
hospitalizations in the United States.

Novartis progress in heart failure
RLX030 (serelaxin) is a recombinant form of the human hormone
relaxin-2 which occurs naturally in both men and women. The results
presented at AHA are consistent with those of a Phase II
dose-ranging study called Pre-RELAX-AHF which investigated RLX030
in 234 patients with AHF. This study indicated that RLX030 improved
dyspnea and suggested the potential for longer-term benefits.

Novartis and its wholly owned subsidiary Corthera Inc. have the
exclusive worldwide rights to RLX030 (except in Canada).

Disclaimer
The foregoing release contains forward-looking statements that can
be identified by terminology such as "may," "prospect,"
"suggesting," "encouraging," "committed," "potential," or similar
expressions, or by express or implied discussions regarding
potential marketing submissions or approvals for RLX030, or the
timing of any such submissions or approvals, or regarding potential
future revenues from RLX030. You should not place undue reliance on
these statements. Such forward-looking statements reflect the
current views of management regarding future events, and involve
known and unknown risks, uncertainties and other factors that may
cause actual results with RLX030 to be materially different from
any future results, performance or achievements expressed or
implied by such statements. There can be no guarantee that RLX030
will be submitted or approved for sale in any market, or at any
particular time. Nor can there be any guarantee that RLX030 will
achieve any particular levels of revenue in the future. In
particular, management's expectations regarding RLX030 could be
affected by, among other things, unexpected clinical trial results,
including unexpected new clinical data and unexpected additional
analysis of existing clinical data; unexpected regulatory actions
or delays or government regulation generally; competition in
general; government, industry and general public pricing pressures;
unexpected manufacturing issues; the company's ability to obtain or
maintain patent or other proprietary intellectual property
protection; the impact that the foregoing factors could have on the
values attributed to the Novartis Group's assets and liabilities as
recorded in the Group's consolidated balance sheet, and other risks
and factors referred to in Novartis AG's current Form 20-F on file
with the US Securities and Exchange Commission. Should one or more
of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially
from those anticipated, believed, estimated or expected. Novartis
is providing the information in this press release as of this date
and does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new
information, future events or otherwise.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals
Corporation is an affiliate of Novartis AG, which provides
innovative healthcare solutions that address the evolving needs of
patients and societies. Headquartered in Basel, Switzerland,
Novartis offers a diversified portfolio to best meet these needs:
innovative medicines, eye care, cost-saving generic
pharmaceuticals, preventive vaccines and diagnostic tools,
over-the-counter and animal health products. Novartis is the only
global company with leading positions in these areas. In 2011, the
Group's continuing operations achieved net sales of USD 58.6
billion, while approximately USD 9.6 billion (USD 9.2 billion
excluding impairment and amortization charges) was invested in
R&D throughout the Group. Novartis Group companies employ
approximately 127,000 full-time-equivalent associates and operate
in more than 140 countries around the world. For more information,
please visit http://www.novartis.com.

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